TY - JOUR
T1 - Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA)
AU - Herborn, Christoph U.
AU - Honold, Elmar
AU - Wolf, Michael
AU - Kemper, Jörn
AU - Kinner, Sonja
AU - Adam, Gerhard
AU - Barkhausen, Jörg
PY - 2007/1/1
Y1 - 2007/1/1
N2 - OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
AB - OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
UR - http://www.scopus.com/inward/record.url?scp=33846107792&partnerID=8YFLogxK
U2 - 10.1097/01.rli.0000248893.01067.e5
DO - 10.1097/01.rli.0000248893.01067.e5
M3 - Journal articles
C2 - 17213750
AN - SCOPUS:33846107792
SN - 0020-9996
VL - 42
SP - 58
EP - 62
JO - Investigative Radiology
JF - Investigative Radiology
IS - 1
ER -